Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

LeMaitre Vascular

Status and phase

Terminated

Phase 2

Conditions

End Stage Renal Disease

Treatments

Device: Expedial Vascular Access Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT00131872

00168

Details and patient eligibility

About

The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

Enrollment

172 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has chronic renal failure and requires vascular access for hemodialysis
Patient has given informed consent to participate in the trial and is willing to comply with the study protocol
Patient is male or female, 18 years of age or older
The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
Patient has a vein 4 mm or larger to which the graft can be anastomosed

Exclusion criteria

Patient is unable to comply with the study follow-up
Patient has a known sensitivity to polyurethane or porcine heparin
Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
Patient has an immunodeficiency syndrome
Patient has a prior history of bacterial infection within 8 weeks of implantation of graft
Patient has a severe coagulation disorder
Patient has an elevated platelet count of greater than 1 million
Patient has a history of heparin-induced thrombocytopenia syndrome (HIT)
Patient is pregnant
Patient has a fever greater than 100 degrees Fahrenheit